FDA.reportPublic FDA data

Cialis

Product NDC
43353-857
Requested package NDC
43353-857-12
11-digit product format
433530857
Labeler code
43353
Product ID
43353-857_1afa3b7e-517b-40fb-a0e2-95fdc60d9803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021368
Marketing category
NDA
Marketing start
2003-11-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-85743353-857-12IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021368-001CIALISTADALAFIL5MGTABLET / ORALAB1RLD2003-11-21
N021368-002CIALISTADALAFIL10MGTABLET / ORALAB1RLD2003-11-21
N021368-003CIALISTADALAFIL20MGTABLET / ORALAB1RLD, RS2003-11-21
N021368-004CIALISTADALAFIL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021368-001AB1
N021368-002AB1
N021368-003AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-004CIALIS2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021368-001AB11a50c72e98297…
2026-08-01 22:54:322026-06N021368-002AB11a50c72e98297…
2026-08-01 22:54:322026-06N021368-003AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CialisTADALAFILEli Lilly and Companybcd8f8ab-81a2-4891-83db-24a0b0e258952026-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 021368
application number: NDA021368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-857-022023-01-30C16284748780-1f386c649-bea2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-042023-01-30C16284748780-1f386c649-bea2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-062023-01-30C16284748780-1f386c649-bea2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-122023-01-30C16284748780-1f386c649-bea2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-857-02Cialis2 in 1 BOTTLE, PLASTICTABLET, FILM COATED23
43353-857-04Cialis4 in 1 BOTTLE, PLASTICTABLET, FILM COATED43
43353-857-06Cialis6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63
43353-857-12Cialis12 in 1 BOTTLE, PLASTICTABLET, FILM COATED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-857-02EA - Each43353-857315fd858-55be-4402-b7a4-ffe703b43b7112014-04-03
43353-857-04EA - Each43353-8571b006ed3-0dcb-46f1-a583-02714c78e8e612014-04-03
43353-857-06EA - Each43353-85776bc1581-2821-476b-a515-ce5755eac20912017-12-14
43353-857-12EA - Each43353-8578aecb9f2-ae3f-4664-9a76-41c8f1522f2612017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-857CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 4 package rows20191221_1da40b7c-c96a-45d2-a3f2-fafad429afd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402097Cialis 20 MG Oral TabletPSN1da40b7c-c96a-45d2-a3f2-fafad429afd63
402019tadalafil 20 MG Oral TabletPSN1da40b7c-c96a-45d2-a3f2-fafad429afd63
402097tadalafil 20 MG Oral Tablet [Cialis]SBD1da40b7c-c96a-45d2-a3f2-fafad429afd63
402019tadalafil 20 MG Oral TabletSCD1da40b7c-c96a-45d2-a3f2-fafad429afd63
402097Cialis 20 MG Oral TabletSY1da40b7c-c96a-45d2-a3f2-fafad429afd63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-857-124335308571212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-857-12) 2015-02-260000-00-00NoNoCurrent